The Efficacy and Cost Effectiveness of Preoperative and Postoperative Cryotherapy in Proximal Tibia Fractures (ARCTIC CAT)
|ClinicalTrials.gov Identifier: NCT01104831|
Recruitment Status : Terminated (Inadequate recruitment.)
First Posted : April 16, 2010
Last Update Posted : May 8, 2017
Consenting patients with proximal tibia fractures will be randomized to 10 degree or 21 degree cryotherapy sleeves. Time to discharge and complications will be monitored.
Primary outcome measure: Cost of Treatment (based on length of stay) Secondary outcome measures: Satisfaction/pain relief and narcotic requirement
|Condition or disease||Intervention/treatment||Phase|
|Proximal Tibia Fracture||Device: Cryotherapy Device: Room temperature cuff||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||The Efficacy and Cost Effectiveness of Preoperative and Postoperative Cryotherapy in Proximal Tibia Fractures|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||November 2012|
Placebo Comparator: 21 degree Cooling
Room temperature water circulated through cryotherapy sleeve.
Device: Room temperature cuff
sleeve with room temperature water placed over fracture site.
Active Comparator: 10 degree cooling
Cooled water circulated through a cryotherapy sleeve.
cooled sleeve placed over fracture site.
- Cost [ Time Frame: 3 months ]
- VAS Pain Score [ Time Frame: 2 weeks ]
- Narcotic Requirements [ Time Frame: 2 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01104831
|Winnipeg Health Sciences Centre|
|Winnipeg, Manitoba, Canada, R3A 1R9|
|Principal Investigator:||Jesse A Shantz, MD, MBA||University of Manitoba|